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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
This study has been completed.
First Received: January 24, 2007   Last Updated: October 14, 2009   History of Changes
Sponsor: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00426803
  Purpose

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.


Condition Intervention Phase
Intracerebral Haemorrhage
 Drug: activated recombinant human factor VII
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Reducing haematoma growth [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reducing disability and improving clinical outcome [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: August 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426803

  Show 36 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Nicolai C. Brun, MD, Ph.D Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers: F7ICH-1371
Study First Received: January 24, 2007
Last Updated: October 14, 2009
ClinicalTrials.gov Identifier: NCT00426803     History of Changes
Health Authority: Taiwan: Department of Health;   Spain: Spanish Agency of Medicines;   Singapore: Health Sciences Authority;   United Kingdom: Medicines Control Agency;   Croatia: Ministry of Health and Social Care;   Denmark: Danish Medicines Agency;   Canada: Health Canada;   Finland: National Agency for Medicines;   Netherlands: Dutch Health Care Inspectorate;   New Zealand: Food Safety Authority;   Austria: Federal Ministry for Health and Women;   Germany: Paul-Ehrlich-Institut;   Italy: National Monitoring Centre for Clinical Trials - Ministry of Health;   Switzerland: Swissmedic;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Norway: Norwegian Medicines Agency;   Sweden: Medical Products Agency;   United States: Food and Drug Administration;   Malaysia: Ministry of Health

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
 Cardiovascular Diseases
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 09, 2009



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